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December 28, 2009

Gene Patenting: Australian Potpourri

Gene patenting, and proposed bans on the practice,
have garnered several newspaper reports and responses from professional groups
around the world.

Australian
Senate Panel Debates Gene Patenting

The Community Affairs Committee of the Australian
Senate is investigating whether genes should be patentable in that country,
according to a December 12th report in The Australian ("Patently tricky dispute drags on: who owns your genes"). The
debate was sparked, according to a report, by a letter from Genetic
Technologies (GTG), a Melbourne testing lab, to eight public pathology
laboratories regarding its rights to testing the BRCA1 and BRCA2 genes, under
an exclusive license from Myriad Genetics.The report notes that any aggressive enforcement of GTG's
licensed rights under the Australian patents may have been stayed by a change
in the company's board of directors, as well as the uncertainty created by the
lawsuit in New York brought by the ACLU over the corresponding U.S. patents.

The Senate panel held six public "inquiries"
from March through September 2009, and received 72 primary and several
additional submissions from various individuals and groups.Predictably, the account reports that
these submissions fall into two groups:those that contend that gene patenting under Australian law is proper
and is having the desired effects of promoting investment and access, and those
who contend that it is ethically wrong to permit genes to be patented.Another important aspect of the debate
in Australia is its international commitments and agreements, which would
prevent Australia from "going it alone."

The opposition bases its arguments on purported ethical
concerns, and additionally proposes a "middle ground" based on
copyright, wherein "[a]nyone who wants to use your IP must tell you and
pay you," according to Luigi Palombi (at left), a gene patenting opponent and
Australian National University patent law expert.Ironically, this idea is the reverse of the canard spouted
by the late author Michael Crichton in the op-ed pages of The New York Times, to the effect
that gene patent holders could ask individuals for infringement damages because
their cells were using the patented genes.(For anyone not reading this space, that assertion is
false.)It is hard to imagine how
the scheme proposed by Professor Palombi would encourage or even permit
development of genetic-based technologies in Australia.

One other academic is cited in the piece, Professor
Laurie Zoloth (at right) of Northwestern University.Two quotations stand out:first, she asserts as an argument against gene patenting that it would
be like "[p]atenting the sun."This phrase, the title of a biography of Dr. Jonas Salk and his
development of the polio vaccine, loses some of its rhetorical force when one
realizes that Dr. Salk tested his vaccine on the children in a local
home for the mentally retarded, with little if any oversight and neither
parental or any other kind of informed consent.One of the reasons genetic technologies are so
cost-intensive is that such practices, as well as other, more well-known consequences
of lax regulation like the Thalidomide and diethylstilbestrol disasters,
resulted in more stringent regulatory oversight.Accordingly, the cost of bringing a new drug or therapy to
market is much higher in view of these requirements, but the alternative is
unthinkable.This is particularly
the case for genetic testing having the consequences of detecting BRCA1 or
BRCA2 mutations.Patents on genes
support the investment needed to ensure that the genetic tests that come to
market are reliable, and that we don't develop the genetic equivalent of "patent"
medicines.

The other quote from Professor Zoloth that stands
out is her assertion that genetic information should be part of a "creative
commons" that is freely available to all comers, and that "[e]ventually
the work will be commercialized," purportedly being the role of venture
capitalists and philanthropy.The
depths of misunderstanding in this statement are chilling:first, the information relating to genes is
part of the "creative commons" insofar as anyone wants to use that
information.The proof of this
statement is in the nearly 3,500 scientific journal publications that can be
accessed from public databases like PubMed merely by typing "BRCA1"
or "BRCA2" into the search engine.The latest of these papers was published this fall,
something directly contrary to the assertions that gene patenting inhibits
basic research.If that were the
case, the number of these publications would have decreased dramatically once
the patents were granted.And if that
were the case, it would not have been the conclusion of every single study done
to date that patenting has not had an inhibiting effect on genetic
research.And, of course, the blasé
statement from Professor Zoloth that "[e]ventually the work will be
commercialized" ignores the realities that nothing will be commercialized
that cannot be protected (unless her use of the word "eventually" is
in the historical sense).While it
may be true that such things would "eventually" happen, it is
undoubtedly true that under a gene patenting ban they would happen much more
slowly, if at all.In human terms,
that means less diagnostic and therapeutic advances and more suffering.Funny position for a bioethicist to be
taking.

The Australian Senate panel has postponed its
report, originally due in November until March 18, 2010.It's possible that the committee has
realized that the issue is more complicated than simply deciding gene patenting
is "wrong."Perhaps it
will realize in the ensuing months that gene patenting is necessary, and
beneficial, for Australia and the rest of the world.

A panel put on by the Institute of Patent and
Trademark Attorneys of Australia (IPTA) strongly supported gene patenting in
Australia, saying the ban proposed by opponents would "bring the
Australian biotech industry to its knees," according to independent reports
by the Australian AP and Australian Life
Scientist ("Ban drives 'biotech industry to its knees'").The reason:the difficulties in attracting
investment without patent protection, according to Trevor Davies, IPTA
councilor."[I]f biological
materials couldn't be patented . . . there is a likelihood that important
advances in medicine would not be realized in Australia because there wouldn't
be patent protection," he said.

The panel, made up of patent lawyers, biotech
entrepreneurs, and academics, analogized the importance of patents for
biotechnology with mining leases in the mining industry, and reminded listeners
that the cost of "transforming a promising field of research into a
market-ready product -- like a life-saving medical test -- was about a billion dollars."Without patent protection, the panel
said that biotech or pharma companies simply would not support investment in
this work.Banning gene patents
would "remove the incentive for people to invest," according to
University of Melbourne patent law professor Andrew Christie (at left).Professor Christie rebutted the
frequently-heard complaint that patenting genes somehow gives patent-holders "control"
over an individual's body, saying in effect nobody "owns you."

Dr. Tania Obranovich (at right), a patent attorney and former
research scientist, stated that permitting gene patenting encourages private
investment which facilitates bringing therapies to market.She reminded the audience that
Gardisil, the cervical cancer vaccine, would not have gotten to market without
protection of certain human papilloma virus genes.Dr. Obranovich also contended that gene patents do not
inhibit basic research.

The panel made one concession to the protests of
the anti-gene patenting crowd:they supported a change in Australian law to clarify that basic genetic
research using patented genes would not constitute an infringing act, based on
some uncertainty in how Australian law has been interpreted by the courts.

Australian
Cancer Researcher Against Patenting Genes

Professor Ian Frazer (at right), President of Cancer Council
Australia (as well as former Australian of the Year and inventor of the
cervical cancer vaccine) wrote an article in The Australian in August critical
of gene patents ("Sharing genes is patently obvious: gene patent inquiry").Professor Frazer
is entitled to his opinion, of course (although it is unlikely that the
cervical cancer vaccine is unpatented), but his arguments would be more
persuasive if fewer of his statements in support of them were less fantastical.

For example, Professor Frazer contends that "there is no more invention in isolating and
characterising biological material that exists in our bodies, using existing
research techniques, than in collecting and arranging a set of postage stamps."Even insofar as this statement can be
interpreted as commenting on advances in biotechnology over the past
twenty-five years, it ignores (even rhetorically) the difference between a gene
in a chromosome and an isolated copy (typically a cDNA copy) of that gene.While the Human Genome Project has set
forth thousands of previously-unknown open reading frames in chromosomal DNA
(sections that could, but do not necessarily, encode for protein), the apt
analogy is not with postage stamps.It is with a parts list for an automobile, in which you try to assemble
it without being able to look under the hood.While the amount of genetic information obtained over the
past decade has been monumental, it is inchoate with regard to the function, if
any, of most of it.This will
preclude patentability for many genes, but it should not preclude
patent-eligibility. Second, Professor Frazer states, "claiming a
monopoly on the use of a particular gene sequence in an already existing
diagnostic test method can lead to restricted public access to vital diagnostic
services."Ignoring the
rhetorical flourish of "monopoly,"there
is no "already existing diagnostic test method" for diagnosing a
particular disease, or propensity for contracting a disease, in the absence of
the "particular gene sequence."Even then, the mere existence of the gene sequence is not enough:a sufficiently high correlation must be
established so that the result of an assay for a particular mutation reliably
indicates that a patient does, or does not, have a higher likelihood of disease
than the "wildtype" population.Identifying the sequence, establishing the correlation and satisfying
regulatory requirements that would prevent unreliable tests from coming to
market requires investment, which requires some way to increase the likelihood
for a return on that investment.Patents do that.

Professor Frazer's argument, as he develops it, is
rooted in a mistaken belief that permitting genes to be patented will inhibit
basic research.He alleges that
permitting genes to be patented can eliminate "the competitiveness and information sharing essential
to the development of genetic therapies," which therapies he conceded
should be rewarded by a patent.He
cautions against restricting use of patented genes in research, which could "delay
the development and testing of truly inventive and practical uses of the gene
and its protein product for diagnosis and therapy."The problem with this argument is there
is no evidence for it:study after
study has shown that patenting does not restrict research use of patented genes, and even the most notorious of the
patented genes, BRCA1 and BRCA2, have been the subject of almost 3,500 research
papers published in the scientific literature in the face of patents on those
genes.

Professor Frazer also says that the "collegial tradition of sharing raw data among
researchers must be allowed to continue unfettered so new technologies can be
developed to benefit all."Maybe science is practiced differently in Australia, but the
collegiality of data sharing in academia is typically severely limited to data
already submitted to a scientific journal for publication.Ironically, patenting (including gene
patenting) fosters collegiality since it establishes a legal priority date for
an inventor's invention.

The Professor also
cites "Pasteur's immunology discoveries" and "Florey's
penicillin antibiotic" as examples of inventions "gifted to humankind
for global benefit."On the
contrary, Louis Pasteur patented what was commercially-valuable to him in the
19th century (improved yeast strains for winemaking) and the tragedy
of Florey's "gift" of penicillin is well-know to have required World
War II for its commercial development under government grants; prior to the war
no pharmaceutical company would commercialize penicillin precisely because
there was no patent protection to stimulate investment.

Professor Frazer
ends his piece by recommending that, until gene patenting is banned in
Australia, "non-commercial use of gene sequence information should be
encouraged for research and diagnostic purposes."Ironically, if Australia bans gene
patents such "non-commercial use" is all Australians are going to
have.

Comments

Kevin,

I quite agree that patents on DNA sequences can be useful, but I fear your zeal to make this point has led you to overshoot your mark.

1. HPV patents. The Frazer you attack is the inventor whose patent on technology underlying Gardasil and Cervarix finally won a six-way interference in a CAFC appeal (involving Univ Queensland, Rochester, US National Cancer Institute and Georgetown). I think he probably knows something about patents in his own experience. It is far from clear what would have happened without those patents. Merck and GSK might not have developed their products, but the public health need is driving vaccine development in several Indian companies and elsewhere. And while Merck has been mounting trials in places where women die of cervical cancer (mainly Asia, Africa and South/Central America), it is the sad case that this marvelous and potentially life-saving technology is mainly available where cervical cancer screening is already good (and few lives are at stake) and unavailable where it would save those lives. It's a technical success story, but has yet to turn into a public health success story, and both sides should be cautious in over-claiming. This is one reason you'll find some of the scientists who were involved in HPV vaccine development are not cheerleaders for the current patent system--even those, like Frazer, who used it.

2. Penicillin. It is flat wrong that the main reason private pharmaceutical firms did not develop penicillin is lack of a patent incentive. Kingston and Neuschul have told that story well. Fleming did not pursue clinical use and it was Chain and Florey who took up the cause and saw the therapeutical possibilities. A wartime need drove R&D (and much of the important work was done on fermentation at USDA labs in Peoria), subsidized production, and guaranteed contract purchases for the final product. Your assertion that having a penicillin patent would have led to investment is almost certainly wrong, given the state of the science at the time. The missing ingredient was not money or exclusivity.

3. Salk & polio vaccine. Laurie Zoloth's comment does indeed echo Salk's quote to Edward R. Murrow "Would you patent the sun?" Jane Smith, in the book you allude to, shows he was doing a bit of grandstanding, and U Pitt would probably have patented his vaccine if they thought they could. They concluded they couldn't because of prior art the the patent law interpretations of their day.

And you're right that the ethical standards for human medical research were different then--there were no IRBs and no 45 CFR 46 regulations. But I don't think that has much to do with patenting.

4. Finally, the outrageous comment that it takes a billion dollars to develop a genetic test simply can't be even close to true. U Penn and 8 other labs were "cleared from the market" by Myriad, meaning those 9 labs already had BRCA tests available as a service. Similar stories are true for long-QT testing, ApoE genotyping, Duchenne testing, etc., where a private lab shut down testing at labs already offering a genetic test. It is demonstrably false that patent incentives are *necessary* to develop genetic diagnostics once the genotype-disease association has been published. It's certainly true that exclusivity can also get companies to offer such tests, and we can have a discussion about the net social benefit of that real effect of patents. You don't quite claim that patents are necessary to develop diagnostics, but you certainly imply it.

Finally, re the 3500 articles that have been published on BRCA. I agree it's hard to argue there's been a big chill attributable to the BRCA patents. But you overshoot when you say all the studies show no effect. Fiona Murray has two papers showing a modest dampening effect on research associated with patents, one in Nature Biotech articles and more recently looking at the Jensen & Murray DNA-sequence patents from their Science article.

I actually think the "research effect" is potentially interesting, because given the breadth of the claims, particularly US Patent 5,747,282, virtually all those 3500 papers would have involved use of isolated DNA molecules covered by the claims, and therefore infringing uses for any work done in the US, Canada, or Australia/New Zealand. Such pervasive infringement can't be a good thing, can it? Myriad deserves credit for allowing (sometimes collaborating in) such work, but I do think that post-Madey, the situation is metastable.

We don’t attack people here; we just point out our disagreements with their positions (sometimes forcefully).

Before I address your points, I need to put the discussion in context. Both here in the US in the ACLU case, and in Australia, the effort is not just to have courts (or the legislature) examine whether genetic diagnostic methods should be patentable. We could have an interesting discussion on this point, with pros and cons on both sides. But both the ACLU and the academics like Ian Frazer have taken the position that genes should not be patentable. And they have “supported” their position with “falsehoods, exaggerations and downright lies” (to paraphrase an earlier post), some of which I addressed. So any zealotry you discerned in the post was an effort to push back against this sort of distortion.

Turning to your substantive points, Mr. Frazer’s position has the whiff of hypocrisy to me – “patents for me but not for thee.” I’m sure he is a brilliant scientist, but in my experience brilliance in one field does not translate well to others, particularly ones in which one has no training, has strongly-, emotionally-based views, and gives someone a chance to voice an “influential” opinion on public policy questions. Sometimes that is a wonderful addition to the debate – Linus Pauling on nuclear weapons, for example. (But then, recall that Albert Einstein, speaking of Pauling, once said “Now, there is a genius.”) I don’t find Mr. Frazer’s contribution to have the same qualities.

The “billion dollar” figure was not directly related to genetic diagnostics, but encompassed biologic drug development because that is where the anti-gene patenting crowd has put the debate. I don’t know how much it costs to develop genetic diagnostic tests, but I suspect it is much more expensive that those of us who don’t do it may think.

As for the university hospitals, I have two comments. First, I am sure that they believe they can compete with Myriad in providing the tests. I have no idea if they can, but I do know that at least one of the hospitals on your list had a project on gene therapy shut down when a child died. This is tragic, but it points out (once again) that brilliant scientists are not always the people who we should entrust with bringing a product to market. “The best and the brightest” are not always the ones who can do the best or be the brightest, as we have seen multiple times on many fronts.

And, of course, I don’t think these university hospitals are offering to perform the tests for free. In my view, they want to wrap themselves in the cloak of selfless dedication to their patients while they operate a money-making diagnostic testing center. I don’t see them has wearing the white hats (the white coats, maybe) on this issue.

As for the non-existent “research exemption” to patent infringement, I agree that the fact that no basic researcher has been sued is a metastable state, but the fact is that study after study says that basic researchers pay no attention to patents when it comes to their research. (Indeed, institutionally-mandated Material Transfer Agreements are much more burdensome.) This fact, and the plethora of research articles on BRCA1 and BRCA2 (and the steady increase thereof) was mentioned to counter the falsehood that gene patents hinder research. There is no tragedy in the anticommons – it was a clever idea, but sometimes reality has to enter into the debate. It’s a little pathetic that “a modest dampening effect” is the best that can be done to support the “gene patents hinder basic genetic research” argument.

As for Dr. Salk, my point was that Jonas Salk as a standard bearer of ethical scientific behavior is ludicrous, in view of his treatment of retarded children as guinea pigs.

Finally, we can disagree about penicillin – reconstructing history is an inexact science at best. But any time a pharma company invests a lot of money on something, the odds of that something being commercialized go up – not very high, perhaps, because ultimately it depends on the science, but the chance are better than with no investment. And raising investment is supported by patenting.

But as always, you raise good points. Thanks for the comments, and Happy New Year.